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IMPORTADO POR SANOFI AVENTIS DE

⚠️ Moderate Risk

FEI: 3016778977 • Cali • COLOMBIA

FEI

FEI Number

3016778977

📍

Location

Cali

🇨🇴

Country

COLOMBIA
🏢

Address

Cra 9 30125 No 101 67 P, , Cali, , Colombia

Moderate Risk

FDA Import Risk Assessment

45.6
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
1/19/2023
Latest Refusal
1/19/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
26.4×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
1/19/2023
62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is IMPORTADO POR SANOFI AVENTIS DE's FDA import refusal history?

IMPORTADO POR SANOFI AVENTIS DE (FEI: 3016778977) has 1 FDA import refusal record(s) in our database, spanning from 1/19/2023 to 1/19/2023.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. IMPORTADO POR SANOFI AVENTIS DE's FEI number is 3016778977.

What types of violations has IMPORTADO POR SANOFI AVENTIS DE received?

IMPORTADO POR SANOFI AVENTIS DE has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about IMPORTADO POR SANOFI AVENTIS DE come from?

All FDA import refusal data for IMPORTADO POR SANOFI AVENTIS DE is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.